Sponsors need to submit a meeting package for each meeting type. Please see Summary of the different meeting management procedural goals for a summary of meeting package timelines for each of the meeting types. The purpose of the meeting package is to provide the FDA with a summary of relevant product information that may be needed in response to the issues raised. The contents of the meeting package are intended to be aligned with the meeting objectives and organized. It is recommended that the package is a numbered document with a table of contents, appropriate indices, appendices, and cross references. Some of the information that it should include are:
- Application number
- Product name
- Chemical name, established name, and/or structure
- Proposed regulatory pathway
- Proposed indications
- Dosage form, route of administration (ROA)
- Pediatric study plans or human factors engineering plans (if any)
- List of attendees
- Background section including a brief history of the development program and its current status
- List of proposed questions, grouped by the FDA discipline, and a brief explanation for each
For a list of additional things you can include, please refer to the FDA guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (Guidance for Industry).